Medications: Concerta® – methylphenidate

MEDICATIONS

CONCERTA® is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. (1)

The following have been reported with use of methylphenidate HCl and other stimulant medicines:

Heart-related problems:

sudden death in patients who have heart problems or heart defects

stroke and heart attack in adults

increased blood pressure and heart rate

Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems

new or worse bipolar illness

new or worse aggressive behavior or hostility

Children and Teenagers

new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting CONCERTA®. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with CONCERTA®.

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Other serious side effects include:

slowing of growth (height and weight) in children

seizures, mainly in patients with a history of seizures

eyesight changes or blurred vision

blockage of the esophagus, stomach, small or large intestine in patients who already have a narrowing in any of these organs

Common side effects include:

decreased appetite

dry mouth

trouble sleeping

dizziness

stomach ache

increased sweating

headache

nausea

anxiety

weight loss

irritability

Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. (5.1)

Increase in Blood Pressure: Monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic. (5.1)

Psychiatric Adverse Events: Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychiatric illness. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior. (5.2)

Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures. (5.3)

Priapism: cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of painful or prolonged penile erections or priapism are observed. (5.4)

Peripheral Vasculopathy, including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants. (5.5)

Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (5.7)

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage as indicated. Before performing gastric lavage, control agitation and seizures if present and protect the airway.

Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for pyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for CONCERTA® overdosage has not been established.

The prolonged release of methylphenidate from CONCERTA® should be considered when treating patients with overdose.

10.3 Poison Control Center

As with the management of all overdosage, the possibility of multiple-drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.

The following have been reported with use of methylphenidate HCl and other stimulant medicines:

Heart-related problems:

sudden death in patients who have heart problems or heart defects

stroke and heart attack in adults

increased blood pressure and heart rate

Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems

new or worse bipolar illness

new or worse aggressive behavior or hostility

Children and Teenagers

new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting CONCERTA®. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with CONCERTA®.

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Other serious side effects include:

slowing of growth (height and weight) in children

seizures, mainly in patients with a history of seizures

eyesight changes or blurred vision

blockage of the esophagus, stomach, small or large intestine in patients who already have a narrowing in any of these organs

Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. (5.1)

Increase in Blood Pressure: Monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic. (5.1)

Psychiatric Adverse Events: Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychiatric illness. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior. (5.2)

Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures. (5.3)

Priapism: cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of painful or prolonged penile erections or priapism are observed. (5.4)

Peripheral Vasculopathy, including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants. (5.5)

Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (5.7)

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage as indicated. Before performing gastric lavage, control agitation and seizures if present and protect the airway.

Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for pyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for CONCERTA® overdosage has not been established.

The prolonged release of methylphenidate from CONCERTA® should be considered when treating patients with overdose.

10.3 Poison Control Center

As with the management of all overdosage, the possibility of multiple-drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.

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